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COMPLETED
NCT07787611
PHASE1

Phase I Clinical Study of MWN109 Tablets in Healthy Chinese Participants

Sponsor: Shanghai Minwei Biotechnology Co., Ltd

View on ClinicalTrials.gov

Summary

This is a randomized, double-blind, placebo-controlled, Phase 1 clinical study conducted in China to evaluate the safety, tolerability, pharmacokinetic (PK), and the effect of meal timing following single and multiple oral doses of MWN109 tablets in Chinese participants. The study consists of a single ascending dose (SAD) part and a multiple ascending dose (MAD) part. The SAD part includes 6 dose cohorts, with further evaluation of the effects of different meal-timing conditions at a selected dose level. The MAD part includes 4 dose cohorts administered with once-daily or every-other-day dosing regimens for up to 4 weeks. Approximately 108 healthy participants aged 18 to 50 years are planned to be enrolled. The primary endpoint is safety, assessed by adverse events, serious adverse events, vital signs, physical examinations, laboratory tests, and 12-lead electrocardiograms. The secondary endpoint is the pharmacokinetic characteristics.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Meal Timing Effects Following Single and Multiple Oral Administration of MWN109 Tablets in Chinese Study Participants

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

98

Start Date

2025-06-27

Completion Date

2025-12-20

Last Updated

2026-08-26

Healthy Volunteers

Yes

Interventions

DRUG

MWN109 tablet

A1, A2, A3a, A3b, A3c, A4; administered orally

DRUG

MWN109 tablet

B1, B2, B3, B4; administered orally

DRUG

Placebo

administered orally

Locations (1)

The First Affiliated Hospital of Yunnan University of Chinese Medicine (Yunnan Provincial Hospital of Traditional Chinese Medicine)

Kunming, Yunnan, China